Yeshwanth G.M.
Mechanical Engineer (Engineering & Maintenance in Pharmaceuticals/Life science Industry)
Bengaluru,KA
Summary
· Engineering and Maintenance focused professional with successful 11+ Year career in pharmaceutical/life sciences sector.
· Dedicated team player skilled at mediation and conflict resolution. Drives company growth by supporting through Engineering plannings, handling and on time resolution techniques.
· Agile and adaptable staff leader with stellar work history, motivational approach and upbeat nature.
· Skilled at training employees and leveraging organized approaches to handle daily planning, scheduling and attending of manufacturing requirement, energy & cost saving effectiveness.
· Forward-thinking and industrious with diplomatic communication style focused on maximizing engagement and satisfaction.
· Innovative and goal-oriented individuality & management professional committed to engineering resources.
· Forward-thinking team leader skilled at Engineering & operation departments efficiently to meet goals.
- Successful background with roles & responsibilities for maximum performance.
- Proactive and hardworking individual focused on continuous engineering & operational improvement.
- Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture.
- Documented strengths in building and maintaining relationships with cross functional team in fast-paced settings.
- Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency.
- independent decision-making skills and sound judgment to positively impact on department success.
Overview
12
12
years of professional experience
Work History
Assistant Manager - Engineering & Maintenance
Biocon Limited
07.2018 - Current
- Drive the routine maintenance activity by adopting the predictive maintenance for the process equipment’s and its allied utilities for enhancing productivity, improving quality, reducing downtime, enhancing safety.
- Coordinating activities including work scheduling monitoring progress of work to ensure timely completion.
- Maintenance of machinery equipment’s like freeze driers (lyophilizes), steam sterilisers (autoclave), chromatography column (RPHPLC column), centrifuges, deep freezers, hot air ovens, process reactors (SS), etc. used for manufacturing intermediates in line with the manuals provided by machinery suppliers.
- Analysing the breakdown cause of the machine and find out the proper remedies to eliminate it and to ensure the minimum breakdowns of the equipment’s and the scheduling of day-to-day maintenance work for the core team
- Performed root cause analysis on equipment failures, determining necessary actions to prevent future occurrences of the equipment failure & to ensure the Preventive and breakdown % to be in specified % limit as per requirement from the engineering team by providing on time support.
- To coordinate and provide the support to the team in tandem with the HOD, making sure the team receives zero audit points.
- Ensuring the differential pressures are within the limit on day to day basis and handling of HVAC validation of the clean room facility’s/manufacturing area.
- To prepare and execute the standard operating procedures (SOPs), preventive maintenance schedules and planners for the respective equipment’s and allied utility equipment's on an annual basis.
- To carry out the preventive maintenance as per schedule. To prepare and execute the AMC’s schedules and planners for the respective equipment’s and allied utility equipment's like chillers, HVAC Units, Water plants etc.. on an annual basis.
- Checking daily routine work & maintenance operation of water systems (Purified Water, WFI Water, Pure Steam Generator), HVAC, Chillers, and other allied utility activities.
- Ensure the quality parameter of pure steam quality test for the pure steam generation are with in the specified requirement as per planner.
- Ensuring the temperature validation for the equipment of lyophilizers and autoclave are executing as per the schedule and the temperature requirements are within the limit.
- Performing the inventory for the spares, maintaining the spare stock in order to run the smooth operation of the plant.
- Conducting training programs for improving the technical & personnel skills in down the level staff & workers.
- Maintaining all engineering relevant records and as per ISO, WHO, cGMP standards.
- Hands on experience about the SAP related to engineering activity.
- Hands on experience about the QMS system, handling of deviations, change control, implementation of CAPA through track wise software packages.
- Handling of qualifications, Requalification, validation activities of equipment’s, water system, HVAC systems and other allied utility’s respectively.
- Hands on experience about the software package like eVLMS (Electronic Validated Lifecycle Management System) to handle qualification, re-qualification & revalidation.
- To ensure the all EHS related activities from engineering is in place and followed and also perform various activities held in EHS department.
- Proactively involving in the planning & scheduling of project activities, budgeting, material procurement, inspection, and erection & commissioning & involving in the designing and detailing of the assigned projects related to equipment and utility-associated projects and attending the FAT (factory acceptance test) for the newly procured equipment.
- Selecting the equipment’s according to process requirements, attending the FAT/SAT across verifying against URS and DQ, and executing and coordinating for different qualification works like IQ and OQ for all facility processes and utility equipment’s.
- Managing the installation & commissioning of machines & equipments as part of project & coordination with clients for execution of projects.
- Prepare & share regular updates on project status to Head of Department.
- Proactively involved in develop & monitor project timelines & budgets (CAPEX, OPEX) by coordinating with functional team.
- Conducted extensive research into new technologies and materials, staying ahead of industry trends and contributing to continuous innovation within the company.
- Executing cost saving & energy saving techniques and modifications to achieve substantial reduction & work within the budget.
- Assisted in developing cost-effective solutions to engineering problems & identify the energy-saving aspects and involve them in the identification and implementation to reduce energy-saving losses.
Sr. Executive - Engineering & Maintenance
Hy-Gro Chemicals Pharmtek PVT LTD
03.2013 - 06.2018
- To prepare and execute the standard operating procedures (SOPs), preventive maintenance schedules and planners for the respective equipment’s and allied utility equipment's on an annual basis.
- To prepare and execute the AMC’s schedules and planners for the respective equipment’s and allied utility equipment's like chillers, boiler, HVAC Units, Water plants etc.. on an annual basis.
- Lead the engineering team's audits in tandem with the HOD, making sure the team receives zero audit points.
- Hands on experience about the QMS system (handling of deviations, change control, implementation of CAPA).
- To ensure that all engineering-related documents such as those pertaining to qualification, requalification, validation, and revalidation are prepared and ready for any relevant regulatory, non-regulatory, vendor, and pharmacopeia audits.
- Maintaining all engineering relevant records and as per ISO, WHO, cGMP standards.
- Maintenance of machinery equipment’s like reactors, centrifuge, driers, millers, sifters, blenders, autoclave, steam sterilizers, AHU’s, Water plant, etc, used for manufacturing intermediates in line with the manuals provided by machinery suppliers.
- Leading project team and having exposure handling of HVAC and Purified Water systems.
- Ensuring the differential pressures are within the limit on day to day basis and handling of HVAC validation of the clean room facility’s/manufacturing area.
- Make sure the purified water plants are operational and that their parameters (pre treatment - RO, deionization and mixed bed unit, and purified water storage and distribution loop system) are within the authorized quality parameter in order to prevent any negative effects on the manufacturing facility's operations and quality.
- Actively participated as part of Erecting and Commissioning Team. Hands on experience on all intermediate related machineries and allied utilities.
- Actively participated in Designing and detailing of the project activities with respect process, utilities and entire facility requirements.
- Selecting the equipment’s according to process requirements, attending the FAT/SAT across verifying against URS and DQ, and executing and coordinating for different qualification works like IQ and OQ for all facility processes and utility equipment’s
- Managed to reduce break downs in all utility equipment i.e. HVAC, purified water systems, Boilers, chillers and allied services.
- Implicated trouble shooting procedures for machinery and general utilities pumps, compressors, softeners, RO & water plants systems, HVAC allied service equipments.
- Prepared, impart and implement SOP’s related to maintenance in English and local language & to revised/updated all the SOP’s and imparted training to team members.
- To provide active engineering support in equipment's qualifications and other validation activities and to preparing a drawing (Mechanical, Electrical, Civil) by using Auto Cad for easy maintenance.
Engineer Trainee - Engineering
Reckitt Benckiser Inc.
01.2012 - 09.2012
- Drive the routine maintenance activity by adopting the predictive maintenance for the process equipment’s and its allied utilities for enhancing productivity, improving quality, reducing downtime, enhancing safety.
- Coordinating activities including work scheduling monitoring progress of work to ensure timely completion.
- Maintenance of machinery equipment’s like Air jet washing machine, Filling & Sealing machines, Conveyors and labelling machines.
- To ensure the minimum breakdowns of the equipment’s and the scheduling of day-to-day maintenance work for the core team. Analysing the breakdown cause of the machine and find out the proper remedies to eliminate it.
- Performed root cause analysis on product failures, determining necessary actions to prevent future occurrences of the equipment failure.
- To prepare and execute the standard operating procedures (SOPs), preventive maintenance schedules and planners for the respective equipment’s and allied utility equipment's on an annual basis.
- To carry out the preventive maintenance as per schedule.
- Checking daily routine work & maintenance operation of water systems HVAC & allied utility activities.
- Performing the inventory for the spares, maintaining the spare stock in order to run the smooth operation of the plant.
- Conducting training programs for improving the technical & personnel skills in down the level staff & workers.
- Maintaining all engineering relevant records and as per ISO, WHO, cGMP standards.
Education
Bachelor of Engineering - Mechanical Engineering
Ghousia College of Engineering, Affiliated To VTU
Ramnagar, India06.2011
Associate of Science - Physics, Chemistry, Mathematics, Biology
PES PU College, Affiliated To Pre-university Board
Mandya, India05.2005
High School Diploma -
St.Thomas English High School, Affiliated To KSEEB
Mandya, India05.2003
Skills
- Autocad and Microsoft Packages
- eVLMS (Electronic Validated Lifecycle Management System) Software to handle the qualification activities
- Trackwise software tools to handle the QMS elements
- Basics of C-Language, Microsoft Packages
- Budgeting and costing (CAPEX & OPEX)
- Energy & Cost Saving
- Work Planning and Prioritization
- Teamwork and Collaboration
- Team work, Ability to work under pressure, Hardworking
- Project Planning
- Reliability & Relationship Building
Accomplishments
- As a team coordinator, I successfully completed USFDA, regulatory and non-regulatory audits (OHSAS: 18001:2007, ISO 14001:2004 (Environmental Management Systems), ISO 9001:2008 (Quality Management Systems), drug audits (CDSCO: Central Drugs Standard Control Organisation), and customer and facility audits.
- Completed the projects associated to the product enhancement.
- Completed the factory acceptance test for the process tanks and crystallizer tanks.
- Completed the projects related to new brine chiller installation & commissioning, equipment life cycle management issues, pipe line erection and commissioning as a part of process tech transfer.
- Implemented the energy saving aspects to the water plants WFI system, HVAC, Steam utility, etc.
Languages
Kannada
Advanced (C1)
English
Advanced (C1)
Hindi
Advanced (C1)
Telugu
Advanced (C1)
Tamil
Intermediate (B1)
Bangla
Beginner (A1)
Timeline
Assistant Manager - Engineering & Maintenance
Biocon Limited
07.2018 - Current
Sr. Executive - Engineering & Maintenance
Hy-Gro Chemicals Pharmtek PVT LTD
03.2013 - 06.2018
Engineer Trainee - Engineering
Reckitt Benckiser Inc.
01.2012 - 09.2012
Bachelor of Engineering - Mechanical Engineering
Ghousia College of Engineering, Affiliated To VTU
Associate of Science - Physics, Chemistry, Mathematics, Biology
PES PU College, Affiliated To Pre-university Board
High School Diploma -
St.Thomas English High School, Affiliated To KSEEB
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